Drug major Lupin has initiated a recall of Escitalopram Tablets manufactured at its Goa facility (ANDA approcal received in September, 2012) which is a generic version of Forest Laboratories, Inc.’s (Forest) Lexapro Tablets.
Escitalopram Tablets (3,192 bottles or 319,200 tablets) is used for the treatment of major depressive disorder in adults and adolescents aged 12-17 years. It is also indicated for the acute treatment of general anxiety disorder in adults.
An action basically taken to remove the particular product from the market can be done by either the company itself or by the FDA under its own statutory authority. In this case, it is a Voluntary recall initiated by the company itself.
The recall has been initiated in the US alone and has been classified as a Class III recall which means the exposure to this recalled product is not likely to cause adverse health consequences.
The batches recalled have an expiry date of November, 2017 (fortunately just a single lot) with the recall initiation since March, 2016.
Related Post: Sun Pharma Recalls 12,109 Bottles of Tablets Used To Treat Heart Failure
While not all details have been divulged by the company or the FDA, the simple reason stated is “Labeling: Incorrect or Missing Lot and/or Expiration Date”
While this can be a simple labelling mistake or possible an early expiry product with an over extended expiry date – mostly due to errors in the labelling process of the firm.
The company also recalled another 26,463 Bottles of Lisinopril Tablets (this is a second recall of the same product – read more here on this). No details have changed since the last recall and it’s the same as the previous one with only additionally units. So in total the company has up to now recalled 26,463 Bottles + 26,467 Bottles in the earlier one.
We will wait for the company to issue a press release so as to identify the financial impact of this recall.
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